Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection (MOXIPEDIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01069900
First received: February 15, 2010
Last updated: January 28, 2014
Last verified: January 2014

February 15, 2010
January 28, 2014
July 2010
April 2015   (final data collection date for primary outcome measure)
Primary objective of the trial is to evaluate the safety of treatment with moxifloxacin with a special focus on cardiac and musculoskeletal events. [ Time Frame: Treatment day 5-14 (end of treatment), day 28-42 after EOT (test-of-cure), 3 and 12 months FU ] [ Designated as safety issue: Yes ]
Primary objective of the trial is to evaluate the safety of treatment with moxifloxacin with a special focus on cardiac and musculoskeletal events [ Time Frame: Treatment day 5-14 (end of treatment), day 28-42 after EOT (test-of-cure), 3 and 12 months FU ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01069900 on ClinicalTrials.gov Archive Site
  • Evaluation of musculoskeletal adverse events [ Time Frame: Treatment day 5-14 (end of treatment), day 28-42 after EOT (test-of-cure), 3 and 12 months FU ] [ Designated as safety issue: Yes ]
  • Evaluation of electrocardiogram profiles obtained on Day 1 and Day 3 pre-treatment and post-treatment [ Time Frame: Treatment day 3 and 5 ] [ Designated as safety issue: Yes ]
  • Evaluation of clinical response at the Test-of-cure visit among subjects with a bacteriologically confirmed complicated intra-abdominal infection [ Time Frame: 28-42 days after end of treatment (test-of-cure) ] [ Designated as safety issue: No ]
  • Evaluation of clinical and bacteriological response to treatment at a "during therapy" visit (Day 3-5) [ Time Frame: Treatment day 3 or 4 or 5 ] [ Designated as safety issue: No ]
  • Evaluation of clinical and bacteriological response to treatment at the End of Treatment visit [ Time Frame: Treatment day 5-14 (end of treatment) ] [ Designated as safety issue: No ]
  • Evaluation of clinical and bacteriological response to treatment at the Test-of-cure visit [ Time Frame: 28-42 days after end of treatment (test-of-cure) ] [ Designated as safety issue: No ]
  • Evaluation of musculoskeletal adverse events [ Time Frame: Treatment day 5-14 (end of treatment), day 28-42 after EOT (test-of-cure), 3 and 12 months FU ] [ Designated as safety issue: Yes ]
  • Evaluation of electrocardiogram profiles obtained on Day 1 and Day 3 pre-treatment and post- treatment [ Time Frame: Treatment day 3 and 5 ] [ Designated as safety issue: Yes ]
  • Evaluation of clinical response at the test-of-cure visit among subjects with a bacteriologically confirmed complicated intra-abdominal infection [ Time Frame: 28-42 days after end of treatment (test-of-cure) ] [ Designated as safety issue: No ]
  • Evaluation of clinical and bacteriological response to treatment at a "during therapy" visit (Day 3-5) [ Time Frame: Treatment day 3 or 4 or 5 ] [ Designated as safety issue: No ]
  • Evaluation of clinical and bacteriological response to treatment at the End of Treatment visit [ Time Frame: Treatment day 5-14 (end of treatment) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection
A Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, Oral) Moxifloxacin Versus Comparator in Pediatric Subjects With Complicated Intra-abdominal Infection

The primary focus of the study is the evaluation of the safety of treatment with moxifloxacin in a pediatric population 3 months to <18 years old. Approximately 450 pediatric subjects with a complicated intra-abdominal infection will be enrolled in the study and treated with either moxifloxacin intravenously and orally if switched to oral therapy or ertapenem (intravenously) and, if switched to oral therapy, amoxicillin/clavulanate.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intraabdominal Infections
  • Drug: Moxifloxacin (Avelox, BAY12-8039)
    12-17 years, >= 45 kg body weight: moxifloxacin IV 400 mg OD for a min. of 3 days; if switched to PO: moxifloxacin PO 400 mg OD 12-17 years, < 45 kg body weight: moxifloxacin IV 4 mg/kg q12h not to exceed a total of 400 mg per day for a min. of 3 days; if switched to PO: moxifloxacin PO 4 mg/kg q12h provided as 50 mg tablet(s) 6 - 11 years: moxifloxacin IV 4 mg/kg q12h not to exceed a total of 400 mg per day for a min. of 3 days; if switched to PO: moxifloxacin PO 4 mg/kg q12h provided as 50 mg tablet(s)
  • Drug: Ertapenem, Amoxicillin/clavulanate
    Ertapenem IV 1 g OD for a minimum of 3 days (age 13 to less than 18 years) or IV 15 mg/kg body weight q12h not to exceed 1 g daily (age less than 13 years) If switched to PO: Amoxicillin/clavulanate PO 45 mg amoxicillin/kg body weight q12h not to exceed 875 mg amoxicillin q12h (total treatment duration 5-14 days)
  • Experimental: Arm 1

    2 - 5 years: moxifloxacin IV 5 mg/kg q12h not to exceed a total of 400 mg per day for a min. of 3 days; if switched to PO: moxifloxacin PO 5 mg/kg q12h provided as 50 mg tablet(s). Subjects weighing < 20 kg or being unable to swallow tablets cannot be switched to oral treatment and will continue IV treatment (5 mg/kg q12h) for the entire treatment duration.

    3 months to < 2 years: moxifloxacin IV 6 mg/kg q 12h not to exceed a total of 400 mg per day for a min. of 3 days; Subjects in this age group cannot be switched to oral treatment and will continue IV treatment for the entire treatment duration.

    Total treatment duration all age groups 5-14 days Dosage regimen for other age groups see intervention description

    Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)
  • Active Comparator: Arm 2
    Intervention: Drug: Ertapenem, Amoxicillin/clavulanate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
459
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized males or females 3 months to 17 years of age
  • Able to obtain parental or legal guardian written informed consent and assent from subjects as applicable by local laws and regulations
  • Expected duration of treatment with antibiotics is a minimum of 3 days administered IV, for a total of 5 to 14 days administered IV or IV followed by PO
  • If the subject is a female of child-bearing potential she must have a negative pregnancy test at the screening visit or be capable of practicing an adequate method of contraception, and agree to continue the same method for 1 month following the TOC visit. Lactating subjects are not to be included.
  • Subjects may be enrolled upon a surgically (laparotomy, laparoscopy, or percutaneous drainage) confirmed cIAI revealing at least one of the following:

    • Gross peritoneal inflammation with purulent exudate within the abdominal cavity
    • Intra-abdominal abscess
    • Macroscopic intestinal perforation with diffuse peritonitis OR
  • Subjects may be enrolled on the basis of a suspected cIAI, which must be supported with radiological evidence (ultrasound, abdominal plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of gastrointestinal perforation or localized collections of potentially infected material and at least one of the following:

    • Symptoms referable to the abdominal cavity (eg, anorexia, nausea, vomiting or pain)
    • Tenderness (with or without rebound), involuntary guarding, absent or diminished bowel sounds, or abdominal wall rigidity
    • Fever
    • Leukocytosis
  • The subject must be scheduled for a surgical procedure (laparotomy or laparoscopy) or percutaneous drainage.

Exclusion Criteria:

  • Presumed spontaneous bacterial peritonitis
  • All pancreatic processes including pancreatic sepsis, peripancreatic sepsis, or an cIAI secondary to pancreatitis
  • Early acute or suppurative (nonperforated) appendicitis unless there is evidence of an abscess or peritoneal fluid containing pus and micro-organisms suggestive of regional contamination
  • Infections originating from the female genital tract
  • Known severe immunosuppression. Subjects with known mild immunosuppression (eg, Type I or II diabetes mellitus, trauma, or absolute neutrophil count [ANC] between 1000 and 1500 cells/mm3) may be enrolled.
  • Congenital or documented acquired QT prolongation
  • Receiving concomitant treatment with QT prolonging drugs
  • History of tendon disease/disorder related to quinolone treatment
  • Pathogenic organisms suspected or identified (eg, Pseudomonas) which are resistant to any of the study drugs
  • Abnormal musculoskeletal findings at baseline assessment; or chronic musculoskeletal disease (eg, juvenile rheumatoid arthritis); or chronic illness with high risk for chronic or recurrent arthritis or tendinitis (eg, cystic fibrosis, chronic inflammatory bowel disease)
  • History of myasthenia gravis
Both
3 Months to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   Germany,   Greece,   Hungary,   India,   Latvia,   Lithuania,   Mexico,   Peru,   Romania,   Russian Federation,   Serbia,   Spain,   Ukraine,   United Kingdom
 
NCT01069900
11643, 2009-015578-37, 1962 (Avelox pediatrics)
Yes
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP